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Federal Register

Biomass Denominator Method to Help Antimicrobial Calculations

Federal Register notice: FDA seeks comments on a proposed method for applying a food animal biomass denominator to annual data on antimicrobials sold ...

FDA General

FDA Security Checks Concern Agency Scientists

Science reports that FDA is interpreting new government security requirements more stringently than some other agencies.

Human Drugs

Teva Wants to Intervene in Amgen Sensipar Case

Teva, Barr, and Watson ask the DC federal court for permission to intervene in Amgens suit against FDA trying to reverse the agencys rejection of pedi...

Human Drugs

Trump Lashes Out at Merck CEO After Charlottesville

President Trump lashes out at Merck CEO Kenneth Frazier after he resigned 8/14 from the presidents American Manufacturing Council in protest against i...

Animal Drugs

FDA Proposes Biomass Way of Tracking Animal Antibiotics

FDAs Center for Veterinary Medicine proposes to use a biomass indicator to help it better analyze antimicrobial sales and food-animal population data ...

Human Drugs

FDA Lifts Clinical Hold on CEL-SCI Phase 3 Study

FDA lifts a clinical hold against CEL-SCI Corp. and its Phase 3 cancer study with Multikine (leukocyte interleukin, injection), allowing all clinical ...

Human Drugs

FDA Allows Modified Rating Scale for Omaveloxolone Trial

FDA tells Reata Pharmaceuticals that its modified Friedreichs Ataxia Rating Scale is an acceptable primary endpoint for Part 2 of the companys MOXIe t...

Medical Devices

Medtronic Plans Trial for Drug Therapy with Stent

Medtronic says it will conduct a randomized clinical trial to evaluate one-month dual antiplatelet therapy the combination of aspirin and an anti-clo...

Federal Register

Comments Sought Scheduling Impact on 17 Drugs

Federal Register notice: FDA requests comments about abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes ...

Human Drugs

Lipocine NDA Resubmission for Testosterone Product

Lipocine resubmits an NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associ...